Dr. Herman22:29
First of all, thanks for inviting me to present our study from Munich. I'm honored to be a guest here, especially together with Dr. Marcus, who's a great researcher in the field of arrhythmias, and also I've seen the kind of people that were invited to your talks, and it's really great. So we performed the CABG-AF study in Munich, investigating long-term continuous monitoring of new onset atrial fibrillation after coronary artery bypass grafting. It's a prospective multicenter study. We're funded by the Clinical and the German Research Foundation. The background is the incidence of new onset atrial fibrillation after CABG is around 30% based on registry studies. There's quite a bit of variability, but in large registry studies it says around 30%. The incidence is mainly based on data from telemetric monitoring and intermittent rhythm monitoring and mainly until hospital discharge. So in most studies, time frames didn't extend far past discharge, sometimes up to 30 days, but not much more than that. The current ESC/EACTS guidelines recommend long-term oral anticoagulation should be considered in patients with new onset AF after cardiac surgery. It's a class 2A recommendation. It's a similar recommendation in America in the ACC guidelines. There are a couple issues in our view with these recommendations. First of all, the words 'long-term oral anticoagulation' and then also the fact that it's cardiac surgery and it's not specific types of cardiac surgery because we know that there are differences between different types of procedures and different cohorts of patients. That's the background. The aim of our study was to determine the incidence and the burden of new onset AF in the first 12 months after CABG. It was an investigator-initiated prospective observational study of AF using continuous monitoring in two cardiac surgery centers. We actually planned more centers, but it's such a difficult methodology that it couldn't be expanded much more than two centers. The inclusion criteria were first time isolated CABG for three vessel disease or left main disease, no history of AF or other arrhythmias, and a preoperative left ventricular ejection fraction over 35%. We excluded concomitant cardiac surgery. We just wanted to look at CABG, and we excluded mechanical circulatory support at weaning from bypass. AF was defined based on the algorithm of the implanted monitor at two minutes of AF. The timeline of the study was practically that monitors were implanted at the end of surgery, monitoring started at the end of surgery, continued for one year for the primary endpoint, and then continues until 3 years after surgery. After the three years or after battery depletion, the insertable cardiac monitor can then be removed. Our cohort ended up being 198 patients, with one patient where data collection couldn't be started because the patient died before the whole monitor was initialized. So at the end, we had 197 patients with monitoring data. 25 patients were female, around 13%. It's similar in most CABG cohorts. It's primarily men, which is a limitation of the study. The mean age was 66, which is a typical age for bypass surgery in most cohorts as well. Diabetes was around 40% of patients. A lot of three vessel disease, 50% around left main disease, and primarily bypass surgery on pump, only around 24% off pump surgery. The results: the primary endpoint was the cumulative incidence of new onset AF, and that's shown on the graph on the left. You see that around 48% of patients developed AF in the first year after surgery. That's 95 of the 198 patients. We had a median episode length of 6 minutes, median time to AF or to first AF episode of 3.3 days, and 63% of the episodes were asymptomatic. 67 were not detected in standard monitoring, and the cumulative incidence of AF detected with standard monitoring was around 34%. Here you see the AF burden within the first 12 months after CABG. You see that it's primarily AF in the first weeks, two weeks after surgery. The median AF burden during the first 12 months was 0.07%, which corresponds to 6 hours and 10 minutes of AF. In 90 of the 95 patients who developed AF, the incident episode occurred within the first month, and 77% of the time an AF occurred within the first 30 days after surgery, which you can see in the inset up here showing that most of the AF is in the first month. Here you see an increased burden that's unexpected after 9 months. That's one patient with persistent AF for a time after surgery. If we look at the AF burden by time frame, we see that in the first seven days after surgery, we have a median AF burden of 3.65%. Days 8 to 30, it's 0.04%. And numerically calculating the AF burden, the median burden is 0% after 31 days. There are patients with AF, but if including all the patients, you calculate a median AF burden of 0%. Of the 90 patients with incident episodes in the first 30 days, 19 experienced recurrence after 30 days. That's 21% of the patients, and the median episode length of recurrent episodes was 4 minutes. 97% of recurrent episodes were not detected in standard monitoring. If we look at the episode lengths, we see that most episodes are quite short, under an hour, and only 15 episodes had a length greater than 24 hours. We know this length greater than 24 hours for subclinical AF is relevant because in the ASSERT trial, they found that the stroke risk is higher for subclinical AF with a length greater than 24 hours, and that's why we looked at that specifically. Of the patients who developed these episodes lasting greater than 24 hours, eight had these episodes prior to discharge, and three patients had these episodes after discharge. Before discharge, the episodes were detected in standard monitoring, and after discharge, they weren't detected in standard monitoring. So in conclusion, the incidence of new onset AF in the first year after CABG is higher than previously reported. The AF burden is very low, especially later than 30 days, and given the known bleeding risk with oral anticoagulants, the very low burden questions the current guidelines recommending long-term oral anticoagulation. In our opinion, if oral anticoagulation is initiated for new onset AF, the indication should be reassessed within the first 30 days. Most patients shouldn't be receiving anticoagulants, and if they do, there should be a reassessment. A lot of the data shows that even a year after surgery, patients still have anticoagulants that were started early after surgery. It kind of suggests that once it's started, it's not stopped, and that could be a long-term issue in these patients. That's why we want to motivate people to reassess the actual indication for the medication. So that's the CABG-AF study for you.